Dazodalibep for Sjögren's Syndrome

Recruiting at 224 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland

Disqualifiers: Thrombosis, Polymyositis, Malignancy, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

435 Participants Needed

Trial Summary

What is the purpose of this trial?

Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS. 2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS 3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug Dazodalibep different from other treatments for Sjögren's Syndrome?

Dazodalibep is unique because it targets specific pathways involved in the immune system, potentially offering a more targeted approach compared to traditional treatments that mainly focus on symptom relief. This drug represents a new class of therapies that aim to modify the disease process itself, rather than just alleviating symptoms. ^{1 2 3 4 5}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

This trial is for people with Sjögren's Syndrome who have moderate-to-severe symptoms. Participants must meet the 2016 ACR/EULAR criteria, have certain levels of symptom severity scores (ESSPRI ≥ 5 and ESSDAI < 5), test positive for specific autoantibodies, and still produce some saliva. They should be vaccinated against COVID-19 unless they opt out, not have a history of TB or recent exposure to it, and test negative for TB.

Inclusion Criteria

I show no signs or symptoms of active tuberculosis.

I have been diagnosed with Sjögren's syndrome according to the 2016 criteria.

I have been vaccinated against COVID-19 as per local guidelines or have chosen not to be.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dazodalibep or placebo by IV infusion to evaluate efficacy and safety in Sjögren's Syndrome

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dazodalibep

Trial Overview The study tests Dazodalibep's impact on patient-reported symptoms in those with Sjögren's Syndrome versus a placebo. It also looks at how well Dazodalibep improves systemic activity indicators, patient outcomes, and salivary flow. Safety and tolerability after multiple doses are evaluated as secondary objectives.

Participant Groups

Group I: Dazodalibep Dose 2 Experimental Treatment 1 Intervention

Participants will be administered dose 2 of dazodalibep by IV infusion.

Group II: Dazodalibep Dose 1 Experimental Treatment 1 Intervention

Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion.

Group III: Placebo Placebo Group 1 Intervention

Participants will be administered placebo by IV infusion.

Who Is Running the Clinical Trial?

Horizon Pharma Ireland, Ltd., Dublin Ireland

Lead Sponsor

Trials

31

Recruited

3,700+

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Findings from Research

In a study of patients with Primary Sjögren's Syndrome (PSS) using data from the UK Primary Sjögren's Syndrome Registry, it was found that patients with high symptom burden (HSB) and pain dominated fatigue (PDF) had significantly more comorbidities and were prescribed more medications compared to those with low symptom burden (LSB) and dryness dominated fatigue (DDF).

The research indicates that comorbidities and polypharmacy scores increase with age and body mass index (BMI) across all PSS subgroups, suggesting that these factors may complicate disease management and should be considered in clinical trial designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comorbidities in the UK Primary Sjögren's Syndrome Registry. Tarn, J., Lendrem, D., Barnes, M., et al.[2022]

The EULAR Task Force developed the first evidence-based recommendations for managing Sjögren syndrome (SjS), focusing on symptom relief and addressing dryness, fatigue, and pain, based on a comprehensive review of studies involving primary SjS patients over the last 16 years.

The recommendations include a range of treatment options, from topical therapies like saliva substitutes and artificial tears to systemic medications such as hydroxychloroquine and biological therapies, providing a structured approach for healthcare professionals worldwide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EULAR recommendations for the management of Sjögren's syndrome with topical and systemic therapies. Ramos-Casals, M., Brito-Zerón, P., Bombardieri, S., et al.[2022]

Recent advancements in understanding the pathophysiology of Sjögren Syndrome (SS) have led to the development of targeted treatment options, particularly focusing on B-cell targeted therapies, which show promise for managing systemic manifestations of the disease.

While B-cell therapies are currently the most promising, other treatment pathways, including T-cell co-stimulation and cytokine-based therapies, are also being explored, indicating a potential for significant therapeutic advancements in the next decade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating the Underlying Pathophysiology of Primary Sjögren Syndrome: Recent Advances and Future Prospects. Brito-Zerón, P., Retamozo, S., Gheitasi, H., et al.[2018]

Current studies on oral and biologic disease-modifying antirheumatic drugs for Sjögren's syndrome have not shown significant positive outcomes, indicating a need for better treatment options.

Future improvements in trial design, including multicenter studies and standardized measures, along with new drug developments, may enhance the effectiveness of treatments for Sjögren's syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues related to clinical trials of oral and biologic disease-modifying agents for Sjögren's syndrome. Carsons, SE.[2013]

In a study of 15 French patients with primary Sjögren's syndrome, higher baseline levels of natural killer cells were linked to a lack of response to belimumab treatment, suggesting these cells may play a significant role in the disease.

The findings highlight the importance of considering natural killer cell levels when determining treatment strategies for patients, indicating a need for personalized therapy approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stratifying primary Sjögren's syndrome: killers in the balance? Bowman, SJ., Fisher, BA.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Comorbidities in the UK Primary Sjögren's Syndrome Registry. [2022]

2. England pubmed.ncbi.nlm.nih.gov

EULAR recommendations for the management of Sjögren's syndrome with topical and systemic therapies. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Treating the Underlying Pathophysiology of Primary Sjögren Syndrome: Recent Advances and Future Prospects. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Issues related to clinical trials of oral and biologic disease-modifying agents for Sjögren's syndrome. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Stratifying primary Sjögren's syndrome: killers in the balance? [2018]